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ViewAttendees 36

Medical Devices

Domain: Product Development & Registration

Knowledge Area: Documentation

Clinical assessment: how to minimize the questions from your Notified Body

Thursday, May 11, 2023
11:45 – 12:45 CEST
Location: Pearl 2

Supported By
Description: The experience with MDR to date has clearly shown that clinical assessments are a critical point for both notified Bodies and manufacturers. At this stage in the MDR journey, numerous clinical assessments have been conducted: several of them have not reached a positive conclusion and most of the others have involved numerous iterations of questions and answers with Notified Bodies, often requiring a full revision of the clinical documentation before reaching a successful outcome.
This session will highlight recurring themes and questions emerging from MDR clinical assessments along with insights from Notified Bodies as to what is really expected for both high risk and low risk devices.

Learning Objectives:

  • Upon completion, participants will be able to identify key aspects that often result in Notified Body questions
  • Upon completion, participants will better understand Notified Bodies expectations in the area of clinical evaluation
  • Upon completion, participants will be able to prepare clinical documentation more likely to be processed effectively and efficiently and resulting in a limited number of findings or questions